JP2022512276A - Stent device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a stent device. A stent device comprises a sleeve. The sleeve is formed of a plurality of compressible spring ring elements (21) arranged along the length and has a compressed state and an expanded state. Each ring element has a wavy profile on the surface of the sleeve so that adjacent ring elements overlap at least partially along the longitudinal range of the device. The ring element is compressible against the natural elasticity of the ring element and reduces the outer diameter of the sleeve to allow the compressed stent device to be accommodated in the frangible sheath. Adjacent ring elements are interconnected so as to substantially maintain an axial spacing between the compressed and expanded states. [Selection diagram] FIG. 2A

Description

The present invention relates to a stent device.

In this regard, current treatment methods for aortic dissection and aneurysms primarily utilize conventional surgical grafts and open surgery. Endovascular treatment is also possible. However, maintaining perfusion to all major branch vessels radiating from the aortic arch apex by a purely intravascular approach is complex. Therefore, endovascular treatments are currently very limited.

In addition, when using conventional surgical grafts, it is often necessary to have a complete thoracotomy, i.e., a large surgical opening of the thoracic cavity. This typically requires coronary artery bypass grafting and also requires induction of hypothermia and cardiac arrest. Performing such a surgical procedure is not without the risk of further complications.

In addition, known intravascular stent devices and their delivery systems rely on the use of an internal delivery support shaft, typically a tip integrally molded at its end for ease of insertion. Also equipped with mount loops and release wires for supporting and deploying stent devices. In this type of device, the stent device can be suspended from the delivery system at the tip end. It is held there until the removal from the sheath is complete. It can then be released from the delivery system. Typically, after being released by the release wire, the supporting internal central shaft and chip assembly must then be pulled in through the inside of the device lumen to completely remove it from the inside of the stent device. These items need to be carefully removed to overcome the potential risk of accidentally getting caught and removing the previously deployed device. To provide this functionality, delivery systems typically require other auxiliary elements such as the inner lumen of the shaft and guide wires that pass through the chip part.

Such components cannot, if necessary, anastomosate the unstented end of the device to either the auxiliary device or the original vessel before deploying the stented portion.

It is an object of the present invention to provide an improved stent device that can alleviate the problems associated with those currently available.

According to the present invention, a stent device is provided. The stent device is equipped with a sleeve. The sleeve is formed of a plurality of compressible spring ring elements arranged along the length and has a compressed state and an expanded state. Each ring element has a wavy profile on the surface of the sleeve so that adjacent ring elements overlap at least partially along the longitudinal range of the device. The ring element is compressible against the natural elasticity of the ring element and reduces the outer diameter of the sleeve to allow the compressed stent device to be accommodated in the frangible sheath. Adjacent ring elements are interconnected so as to substantially maintain an axial spacing between the compressed and expanded states.

In this way, the stent device can be compressed to reduce its diameter for insertion purposes. The sleeve is in a compressed restraint when provided within such a frangible sheath. When released from the sheath, the sleeve expands to take a larger diameter by the ring element.

By providing the stent device in a compressible form, integrated column stiffness is obtained. Therefore, an internal delivery mechanism for deploying the stent device can be eliminated. This simplifies the stent deployment process. Also importantly, this avoids the risks associated with the procedure of eliciting such an internal delivery mechanism, especially the disengagement of the stent device that has just been inserted. The externalization of the stent device deployment made possible by the stent device of the present invention further enhances the ability of the stent device to anastomoses to other auxiliary devices or original blood vessels.

Preferably, the wavy profile of each ring element extends around the surface of the sleeve at the outer circumference of the sleeve. Different wavy ring element profiles, such as the "Z" shape, may be employed. However, each ring element preferably comprises a hyperbolic parabolic profile, which is substantially saddle-shaped. In this way, in a compressed configuration, the ring elements can overlap in a scaly manner. Therefore, the ring elements are stacked axially along the length of the sleeve in an overlapping configuration. The overlapping nature of the ring elements in a compressed configuration facilitates the provision of column stiffness for ease of use in deployers. At this point, in a compressed configuration, the peaks of one ring element overlap the valleys of adjacent ring elements. Thus, in a compressed configuration, the close abutment of adjacent ring element portions gives the device column stiffness.

Preferably, the ring elements are arranged such that adjacent ring elements are mounted along the sleeve in order to maintain the relative ring position. In this way, the ring position is maintained across the compressed and expanded states of the stent device.

Conveniently, the ring elements are interconnected by attaching to the sleeve material. Preferably, where adjacent ring elements overlap in the axial direction, their circumferential spacing is the axial spacing of each ring element when transitioning from the extended configuration to the compressed configuration when the device is in the open configuration. It is less than or equal to the maximum change in spread. Therefore, when in the compressed state, tension is applied to the fabric between adjacent ring elements, preventing the adjacent rings from colliding with each other in the axial direction.

Conveniently, the sleeve material is a fabric such as gel coated polyester, for example.

Preferably, the ring element is made from nitinol wire. Conveniently, the wire has a diameter in the range of 0.08 to 0.24 mm.

In addition, the stent device can be equipped with a soft chip at the proximal end. In this regard, if the device is housed in a sheath, the soft tip may extend beyond the ends of the sheath. The soft chip enhances the functionality of the stent device and provides non-traumatic properties that allow the stent device to be deployed without an internal delivery shaft such as known equipment.

Thus, a portion of the proximal end of the stent device may be exposed and covered with one or more soft sutures or PTFE threads to form a non-traumatic tip. In this regard, soft chips can be formed from stent material at the ends of the device. It may include heavy sutures on the saddle profile. In addition, it may include one or more layers of suture on one or more ring elements at the proximal end of the stent device.

A further aspect of the invention provides a stent device comprising a sleeve formed of a plurality of compressible spring ring elements arranged along a length. The soft end tip is formed at the proximal end of the sleeve. The soft end tip comprises a portion of the sleeve covered with one or more soft suture materials or PTFE threads.

In this regard, the soft end tip may be formed from a stent material at the end of the device, folded into a ring and held by a suture.

The soft end tip can be equipped with a heavy suture on a ring element with a saddle profile. In addition, it may include one or more layers of suture on one or more ring elements at the proximal end of the sleeve. With a ring element with a saddle or hyperbolic parabolic profile, the soft tip is naturally rounded, optimizing its non-traumatic properties.

Embodiments of the invention are described by way of examples and with reference to the following drawings.

It is sectional drawing of the conformity deployment apparatus in which the stent device with a sheath of this invention is arranged. It is a figure which shows the stent device of this invention. It is a figure which shows the stent device of this invention. It is a schematic diagram which shows the adjacent ring element of the stent device of this invention.

In this regard, FIG. 1 shows a cross-sectional view of Deployment Device 1 compatible with the stent device of the present invention. The deploying device includes a main body 2 in which the stent device 3 with a sheath of the present invention is arranged.

In this regard, the body comprises a bore 4. The bore 4 allows the sheathed stent device 3 to be located within the bore, but is sized so that the sheath material is not tight enough to prevent it from moving relative to the bore and the stent device.

With respect to the stent device, as shown in FIGS. 2a and 2b, respectively, unsheathed and sheathed, it preferably comprises a lumen or sleeve 20 made of a gel-coated polyester fabric, " A series of springs, such as a "stent element", are fitted, typically a wavy "Z" stent, or, in a preferred embodiment, a saddle ring, i.e. a ring element 21 formed from a nitinol wire in the form of a biconducted parabolic. Equipped with.

The plurality of ring elements 21 are arranged along the axis of the lumen. These are attached circumferentially to the fabric by sutures to form a stent-mounted device portion. The stent-mounted device portion has the ability to be constrained within a tube of significantly smaller diameter, i.e. sheath 40.

As shown in FIG. 2b, compression into a small diameter sheath 40 allows easy insertion of a sheathed stent device (with a properly selected oversize) into the lumen of a branched vessel. Removing the sheath from the stent device allows the stent device to be deployed within the original blood vessel where the stented portion radiates outward. The radially expanding stent element is pressed against the inner wall of the vessel to form an unsewn, sealed joint that fits snugly.

The overlapping nature of the ring elements in a compressed configuration provides a sleeve with column stiffness that facilitates use in a compatibility deployer as shown in FIG.

More specifically, by providing the stent device in a form that can be compressed radially, integrated column rigidity can be obtained. Therefore, an internal delivery mechanism for deploying the stent device can be eliminated. This simplifies the stent deployment process. Also importantly, this avoids the risks associated with the procedure of eliciting such an internal delivery mechanism, especially the disengagement of the stent device that has just been inserted.

In this regard, the ring elements are preferably placed within the sleeve so that the axial spacing of adjacent elements is maintained. In this way, the position of the ring element is maintained across the compressed and expanded states of the stent device.

As shown in FIG. 3, the ring element 21 is a portion where adjacent ring elements overlap in the axial direction, and the distance between them in the circumferential direction ab changes from an extended configuration to a compressed configuration when the device is in the open configuration. It is connected to the sleeve material so that it is less than or equal to the maximum change dL in the axial spread of each ring element during transition. As a result, when in the compressed state, tension is applied to the fabric between adjacent ring elements, preventing adjacent rings from colliding axially with each other.

In this regard, the device can be configured with a relatively high saddle height, i.e. a relatively large axial difference between the peaks and valleys of the ring. Further, preferably, the ring spacing is made smaller than the saddle height so that the peaks and valleys of adjacent rings overlap. This property is utilized to maintain the position of the stent device with respect to the body 2 before and during the process of withdrawing from the sheath by combining with the adjacent portion of the supported fabric.

As shown in FIG. 1, a portion of the stretchable crimped fabric 15, typically gel-coated polyester, can be provided at or near the distal end of the stented portion. This portion is joined and attached by sutures to form a blood-dense, continuous endoprosthesis lumen. In some embodiments, this portion can also include "Y" shaped branched lumens. The non-stented portion can be joined by suturing the endoprosthesis to either the prosthesis body or, optionally, a healthy portion of the original vessel to resume perfusion of blood into the original branched vessel. It is prepared.

Preferably, the sheath is a thin wall (typically a PTFE material) with a unique prior position that ruptures linearly without the need for additional grooves or perforations. The sheath may have three parts. That is, a proximal circular portion slightly longer than the length of the compressed stent mounting portion, a tail portion at its distal end, and an intermediate portion in which the circular portion splits and propagates to the two tail elements.

In the suitability deployer shown in FIG. 1, these flat ribbon-shaped tail elements 7 originate from the ends of the circular portions and can be formed by folding. The formed tail is delivered to a separate strap element through or through the restriction 5 within the body 2 of the suitability deployer. There, they can be tied together to form a single user interface for removing the sheath.

As shown in FIG. 1, the restriction 5 in the bore 2 is configured to prevent the stent device from running. However, this restriction allows the stent device sheath material, i.e., the tail 7, to pass through this restriction for access at the distal end of the body 2.

Any suitable means can be employed to allow the passage of the sheath material beyond the restriction. However, the suitability deployer comprises two arcuate openings 13 facing the restriction 5. The opening extends longitudinally in the axial direction of the body. The openings are substantially circumferential and form an angle of 90-120 degrees. In this regard, each opening provides a passage for the tail of the sheath material 7. The sheath material is divided at a point 9 in the bore 4.

The body comprises a side window 10 that allows the sheathed stent device to be placed within the body with the crimp structure portion 15 of the stent device protruding laterally from the body through the window. Thus, the side window provides a path for the fabric 15 of the non-stented device to pass out of range of the body 2 substantially perpendicular to the axis of the sheathed sheath in the bore, and the stent device. Allows access to the distal end of the. Therefore, this end can be trimmed to a length that matches the anatomy of the individual patient, facilitating ancillary grafts or sutures to the original blood vessel.

Once the stent device is fully deployed, it can be removed from the body 2 of the compatibility device.

In the suitability deployer described above, the body 2 holds and supports the sheathed stent device 3 so that the proximal compressed portion can be inserted into either the original vessel or the auxiliary stent device body. And. As a result, it can be retained for subsequent removal and deployment from the sheath and then resumed perfusion into the vessel.

This simplifies the delivery system in terms of its complexity. This reduces components, reduces procedural steps and potential risks for users, and enables time-efficient and simplified device deployment.

The internal arrangement within the body allows the user to control the division of the sheath as the strap element is pulled. As the sheath is pulled over the internal borearithliction, the circular lumen surface of the sheath continues to divide as it propagates along the two tail elements 7. At the same time, the movement applied to the strap is transmitted to the proximal end of the sheath, which slides over the stent device, allowing the compressed stent device to be released from its radial restraint. Doing so opens the stent device and engages the lumen of the blood vessel.

As shown in FIGS. 1, 2a, and 2b, the stent can have the characteristics of an integrated stent device chip 24. It can be provided at the proximal end of the stent mounting area of the stent device 3. It can project beyond the ends of the sheath when compressed within the restraint of the sheath, partially exposing the compressed stent device element covered with soft suture (or PTFE thread). Provides non-traumatic tip-like features.

Claims (14)

A stent device comprising a sleeve, wherein the sleeve is formed of a plurality of compressible spring ring elements arranged along a length and has a compressed state and an expanded state, each of which is a compressed state. A wavy profile is provided on the surface of the sleeve such that adjacent ring elements overlap at least partially along a longitudinal range of the device so that the ring elements have the natural elasticity of the ring elements. It is compressible against it, reducing the outer diameter of the sleeve to allow the compressed stent device to be accommodated in the frangible sheath, and the adjacent ring element is axial between the compressed and expanded states. Stent devices that are interconnected to substantially maintain the spacing between the stents. The stent device of claim 1, wherein the wavy profile of each ring element extends around the surface of the sleeve at the outer circumference of the sleeve. The stent device according to claim 1 or 2, wherein each ring element comprises a hyperbolic parabolic profile. The stent device according to any one of claims 1 to 3, wherein in a compressed configuration, a mountain of one ring element overlaps a valley of ring elements adjacent in the axial direction. The stent device according to any one of claims 1 to 4, wherein the ring element is interconnected by attaching to a sleeve material. The stent device according to any one of claims 1 to 5, wherein adjacent ring elements overlap in the axial direction, and the device is in an open configuration at an axial distance between the adjacent ring elements. A stent device in which the ring elements are interconnected so that they are less than or equal to the maximum change in the axial spread of each ring element when transitioning from an extended configuration to a compressed configuration. The stent device according to any one of claims 1 to 6, wherein the ring element is formed from a nitinol wire and has a diameter in the range of 0.08 to 0.24 mm. The stent device according to any one of claims 1 to 7, which has a soft chip at the proximal end and the compressed device is housed in a sheath, the soft chip is the sheath. A stent device that extends beyond the edge. The stent device according to claim 8, wherein a part of the proximal end of the device is covered with one or more soft suture materials or PTFE threads. The stent device according to claim 8 or 9, wherein the soft tip is formed from a plurality of sutures at one or more ring elements at the proximal end of the sleeve. A stent device comprising a sleeve formed of a plurality of compressible spring ring elements arranged along a length, wherein the soft end tip is formed at the proximal end of the sleeve and the soft end tip is the soft end tip. A stent device comprising a portion of the sleeve covered with one or more soft suture materials or PEFE threads. 11. The stent device of claim 11, wherein the soft end tip is formed from a plurality of sutures at one or more ring elements at the proximal end of the sleeve. The stent device according to claim 11 or 12, wherein the ring element has an arcuate profile. The stent device according to any one of claims 11 to 13, wherein the ring element comprises a saddle profile.

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